Zynex files a 510(k) for its NiCO, Noninvasive CO-Oximeter device that relies on the companys laser technology.
Moderna, at FDAs urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.
FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its manufacturing of the Eye-Sync eye assessment medic...
Johnson & Johnsons Ethicon Endo-Surgery recalls its Endopath Echelon Vascular White Reload for Advanced Placement Tip surgical stapler due to increase...
The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materials for its Soaanz edema drug contain false and mis...
FDA commissioner Marty Makary and CBER director Vinay Prasad outline a new regulatory framework for annual Covid-19 booster shots and call for new cl...
The Antidepressant Coalition for Education petitions FDA to change labeling for selective serotonin reuptake inhibitors and serotonin-norepinephrine r...
FDA expands its approval of Bayers Jivi for the routine prophylactic treatment of hemophilia A in previously treated adult and pediatric patients aged...
